Pharmacokinetics and Bioequivalence Study of Ranitidine Film Tablets in Healthy Male Subjects

Abstract

The aim of the present study was to compare the bioavailability of ranitidine (CAS 66357-35-5) from two different ranitidine hydrochloride (CAS 66357-59-3) film tablets (Ranitab^© 150 mg film tablets as test preparation and 150 mg film tablets of the originator product as reference preparation). The study was conducted according to an open-label, randomised two-period cross-over design with a wash-out phase of 9 days.

Blood samples for pharmacokinetic profiling were taken up to 24 h post-dose, and ranitidine plasma concentrations were determined with a validated HPLC method with UV-detection.

Maximum plasma concentrations (C_max) of 461.8 ng/ml (test) and 450.6 ng/ ml (reference) were achieved. Areas under the plasma concentration-time curve (AUC_0→∞ of 2,488.6 ng · h/ml (test) and 2,528.8 ng · h/ml (reference) were calculated. The median t_max was 2.83 h (test) and 3.04 h (reference). Plasma elimination half-lives (t_1/2) of 2.78 h (test) and 2.89 h (reference) were determined. Both primary target parameters AUC_0→∞ and C_max were tested parametrically by analysis of variance (ANOVA) and the 90% confidence intervals were between 91.93%-106.98% (AUC_0→∞) and 92.34%-l18.85% (C_max). Bioequivalence between test and reference preparation was demonstrated since for both parameters AUC and C_max the 90% confidence intervals of the T/R ratios of logarithmically transformed data were in the generally accepted range of 80%-125%.

Key words

CAS 66357-35-5 - CAS 66357-59-3 - Histamine H2-receptor antagonists - Ranitab© - Ranitidine hydrochloride, bioequivalence, pharmacokinetics